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510(k) Data Aggregation

    K Number
    K993209
    Device Name
    SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY
    Manufacturer
    THERMOLASE CORP.
    Date Cleared
    1999-12-23

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOLASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use with the beam-shrinking handpiece for the removal or significant reduction in intensity of black and/or blue-black tattoos. The laser, without the beam-shrinking handpiece is also indicated for use in combination with the ThermoLase supplied topical lotion in removing or lightening unwanted facial or body hair and for laser skin resurfacing.
    Device Description
    The SoftLight Q-Switched Nd:YAG Laser Tattoo Removal System consists of the laser device and a beam-shrinking handpiece which is attached to the aperture of the laser. The handpiece focuses the beam from the laser. The absorption of energy from the beam by the dyes in the tattoo results in the formation and liberation of mechanical and heat energy sufficient to lighten the pigment of the tattoo.
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    K Number
    K971207
    Device Name
    SOFTLIGHT Q-SWITCHED (ND:YAG) LASER
    Manufacturer
    THERMOLASE CORP.
    Date Cleared
    1998-05-13

    (412 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOLASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoftLight Q-switched Nd: YAG laser is indicated for use in combination with the supplied lotion for skin resurfacing. It is also indicated for the removal or lightening of unwanted facial or body hair.
    Device Description
    The ThermoLase SoftLight Q-Switched Nd: YAG Laser is designed to deliver a nominal output of 1.0 Joule per pulse at a fixed operating wavelength of 1064 nm in a collimated beam. The pulse repetition rate is 1, 2, 5 or 10 pulses per second (Hz) and single shot. The Q-Switched output pulses are nominally 6-20 nsec in duration. The output beam is delivered through a 7 mirror articulated arm and beam delivery handpiece which allows an easy access to the treatment site. The collimated laser beam gives a fixed spot size of between 6 and 7 mm at the treatment site. This laser can be set to deliver fluences of between approximately 1 to 3.5 J/cm2. The laser energy and repetition rate settings are adjusted and monitored through a microprocessor-controlled key pad on the control panel of the laser. The accessory topical lotion is a suspension of carbon powder, in a base of Light Mineral Oil, NF.
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